Aprepitant injectable emulsion

Heron Therapeutics announced FDA approval of aprepitant injectable emulsion beyond the previous administration method (a 30-minute I.V. infusion) to include a 2-minute I.V. injection for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent substance P/neurokinin-1 receptor antagonist to significantly reduce CINV in both the acute phase (0–24 h after chemotherapy) and the delayed phase (24–120 h after chemotherapy).

The recommended dosage for I.V. injection following highly emetogenic cancer chemotherapy (single-dose regimen) is 130 mg on day 1. Following moderately emetogenic cancer chemotherapy (3-day regimen), the dosage is 100 mg on day 1, with aprepitant 80 mg capsules given orally on days 2 and 3. Treatment with the agent is part of a regimen that includes a corticosteroid and a 5-hydroxytryptamine receptor antagonist.

The most common adverse reactions with the 3-day oral aprepitant regimen in conjunction with MEC were fatigue and eructation. The most common adverse reactions with the single-dose I.V. fosaprepitant regimen in conjunction with HEC were generally similar to that seen in prior HEC studies with oral aprepitant. Infusion-site reactions also occurred.

The most common adverse reactions with single-dose aprepitant were headache and fatigue. The safety profile of aprepitant in healthy participants who received a single 2-minute injection was similar to that seen with a 30-minute infusion.

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